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Senolytics Show Positive Results in Phase 1 Clinical Trial

UNITY Biotechnology reports success in patients with age-related macular degeneration (AMD) and diabetic macular edema (DME).

Scientific AnnouncementScientific Announcement
 

Leading the pack is never easy, but today, UNITY Biotechnology is back with some positive news for senolytics.

Being first is not always easy

UNITY Biotechnology is a company that has been developing senolytics for the removal of senescent cells, which accumulate with age, drive chronic inflammation, and spur various age-related diseases.

Unity was the first company focused on clearing senescent cells to appear and led the pack from its founding some years ago. Unfortunately, being the first is not always easy, and UNITY has had setbacks such as the disappointing news in August 2020, which saw its lead candidate UBX0101 essentially fail to work as intended.

UBX0101 is an MDM2-p53 inhibitor designed to treat osteoarthritis of the knee, but, unfortunately, it failed in its trial. There are a number of potential reasons why: it could be that the target tissue just did not contain enough senescent cells using that particular pro-survival pathway for their removal to achieve much, that senescent cell accumulation does not play a key role in osteoarthritis, that the drug simply did not remove senescent cells, or even that senescent cell clearance in humans is not as beneficial as it is in other animals. The reason remains unclear.

Many people were ready to write UNITY off as a failure at this point, but there was always the potential for it to succeed with one of its other drug candidates, as we pointed out earlier this year.

A second shot on goal

Recently, UNITY announced positive results from its phase 1 study of UBX1325 in patients with advanced DME or wet AMD. The study participants had also reached the point where anti–vascular endothelial growth factor therapy (anti-VEGF therapy) had ceased to be useful.

UBX1325 is different from UBX0101 and targets a different pro-survival pathway that senescent cells use to evade apoptosis, a form of programmed self-destruction that cells should initiate when damaged. UBX1325 works by inhibiting Bcl-xL and is the first senolytic drug that has been used in an ophthalmological context.

The study found that UBX1325 is well tolerated, no adverse effects reported, and no dose-limiting toxicities were observed. While phase 1 studies are conducted in order to determine safety, the majority of participants who were administered UBX1325 showed significant improvement in best-corrected visual acuity, central subfield thickness, and subretinal and intraretinal fluid. This is excellent news, as these are all indicative markers of disease progression.

UNITY has announced that it will now be moving to a phase 2a study to further assess the safety and efficacy of UBX1325 in a larger group of participants with DME. The data for this is anticipated for the first part of 2022.

Also, it is going to be enrolling additional patients with advanced wet AMD in the phase 1 study in order to seek data to support a phase 2a study.

Quotes from the press release

“The imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for disease improvement,” said Jeffrey Heier, M.D., Director of the Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston. “Importantly, UBX1325 is an entirely new treatment modality for eye disease and is particularly exciting for this patient population for whom new therapeutic options could provide significant additional benefits alone or in combination with anti-VEGF agents.” – Source.

Jamie Dananberg, M.D., chief medical officer of UNITY, added, “The patients enrolled in this study had advanced disease for whom anti-VEGF therapies, the standard of care for DME and wet AMD, were no longer thought to be of benefit. Seeing treatment-related improvement in these difficult-to-treat patients is very promising and supports the investigation of UBX1325’s potential as a differentiated, disease-modifying treatment option for a broad patient population. We look forward to further exploring the efficacy of this novel mechanism to alter the course of disease progression in DME patients in the recently initiated Phase 2a study.” – Source.

Conclusion

Tackling the complexity of aging and developing interventions is arguably the greatest challenge humanity has ever faced. Along the way, there will likely be hundreds of failed experiments and studies before the problem is solved. UNITY was the first company to step up and develop senolytic drugs to solve one aspect of aging, and while its first shot on goal missed, this second shot could hit the mark.

The road we have ahead of us is a long one; there will be more failures, and there will be more setbacks, but, importantly, there will also be successes too. We can learn not only through success but also through failure, and as our knowledge and understanding of what aging is and how it works grows, the successes will come more often. This is a good step forward.

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About the author

Steve Hill

Steve serves on the LEAF Board of Directors and is the Editor in Chief, coordinating the daily news articles and social media content of the organization. He is an active journalist in the aging research and biotechnology field and has to date written over 600 articles on the topic, interviewed over 100 of the leading researchers in the field, hosted livestream events focused on aging, as well as attending various medical industry conferences. His work has been featured in H+ magazine, Psychology Today, Singularity Weblog, Standpoint Magazine, Swiss Monthly, Keep me Prime, and New Economy Magazine. Steve is one of three recipients of the 2020 H+ Innovator Award and shares this honour with Mirko Ranieri – Google AR and Dinorah Delfin – Immortalists Magazine. The H+ Innovator Award looks into our community and acknowledges ideas and projects that encourage social change, achieve scientific accomplishments, technological advances, philosophical and intellectual visions, author unique narratives, build fascinating artistic ventures, and develop products that bridge gaps and help us to achieve transhumanist goals. Steve has a background in project management and administration which has helped him to build a united team for effective fundraising and content creation, while his additional knowledge of biology and statistical data analysis allows him to carefully assess and coordinate the scientific groups involved in the project.
  1. Neil
    July 9, 2021

    This is truly fantastic news! I agree, being the first is hard. We should all appreciate UNITY’s blazing the trail and applaud their successes when they come. Let’s hope UBX1325 makes it all the way to FDA approval. That would mark a giant milestone in our field and, hopefully, open the senolytic floodgate. Way to go UNITY!

  2. breakingbulb65
    July 9, 2021

    This is incredible news!

  3. Jan-Willem Bats
    July 11, 2021

    I can’t believe I’m witnessing these breakthrough development milestones first hand. The first drug to visibly revert aging is going to cause a massive snowball effect!

  4. nsogoloff
    July 16, 2021

    let us hope a pill will be out to clear senolytics from the body within the next few years. how long do you think it will take.

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